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Pragmatic trials are studies designed to inform real-world clinical practice. They are often characterized by a focus on the practical aspects of study design, including recruitment and consent in adherence, as well as the use of standard equipment.
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Another example of a pragmatic trial is the Home Blood Pressure Management (HBPM) study, which utilized various investigators and participants from various geographical areas. This kind of heterogeneity, which is vital for pragmatic trials to be reliable and to reduce bias in the results, is also necessary. A high degree of heterogeneity, however, can cause problems with the design of the trial.
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The purpose of pragmatic trials is to simulate real-life scenarios and gain the highest level of validity externally. They are typically commissioned by practitioners and policy makers to aid in their decision-making. They also provide a useful method to determine the causal relationship between an intervention and its results. They should not, however be used to replace the need for explanation studies.
The concept of pragmatism is controversial and there are concerns about whether pragmatic trials should replace tests for explanations or if they should be an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation studies, which prove the validity of a physiological or clinical hypothesis, and pragmatic trials that aid in policy and practice decision-making. They also suggested the framework for pragmatic trials, dubbed PRECIS.2 This tool sought to define the features of a practical trial, including the recruitment process, the design and implementation of the intervention, as well as follow-up.
The number of pragmatic trials is growing. A recent Medline search using the words pragmatic and naturalistic, which was restricted to randomised controlled trials (RCTs), returned 34 articles. These are shown in red on Figure 2. This indicates that the health sciences community is becoming more sensitive to the subject of pragmatics. However, it is important to keep in mind that the majority of these studies were conducted in primary care settings.